Clinical and Radiological Evaluation of Dental Autotransplantation in the Anterior Region in Young Patients

NCT07314580 · tracked via the Priya Life Science Spain tracker

Sponsor

University of Barcelona

Phase

Observational

Started

2019-12-01

Last updated

2026-01-02

Condition(s) studied

Tooth LossTooth Injury

Investigational drug(s) / intervention(s)

Premolar Autotransplantation

Premolar Autotransplantation: Premolar autotransplantation performed using a standardized clinical protocol including digital planning (CBCT and STL models), 3D-printed donor tooth replicas, guided or conventional socket preparation, atraumatic donor extraction, extraoral time under 5 minutes and semirigid splinting. Clinical and radiographic follow-up is performed up to 5 years.

Study summary

This study aims to evaluate the clinical, radiographic, functional, and patient-reported outcomes of premolar autotransplantation used to replace anterior maxillary teeth in young patients. The study has an ambispective observational design, including a retrospective cohort (patients treated between December 2019 and December 2025) and a prospective cohort (patients enrolled until December 2028).

Participants aged 7 to 15 years who received or will receive premolar autotransplantation to replace an anterior tooth will be followed clinically and radiographically for up to 5 years. Outcomes include tooth survival, periodontal and pulpal healing, root development, complications, orthodontic interactions, restorative needs, and patient satisfaction. The study seeks to identify prognostic factors and long-term success indicators for dental autotransplantation in growing patients.

Eligibility

Sex

ALL

Min age

7 Years

Max age

15 Years

Healthy volunteers

Inclusion Criteria: * Patients aged 7 to 15 years. * ASA I classification. * Loss or indication for extraction of a maxillary anterior tooth (teeth 12, 11, 21, or 22) due to trauma, resorption, or restorative reasons. * Availability of a donor first or second premolar with root development between one-half and complete root length. * Ability to complete at least 2 years of follow-up. * Parent/guardian consent and minor assent obtained for prospective cases. Exclusion Criteria: * Patients older than 15 years. * Severe systemic disease. * Inability or unwillingness to attend scheduled follow-up visits. * Lack of a suitable donor premolar.

Primary outcome measure(s)

Number of Autotransplanted Teeth with Clinical and Radiographic Success — Up to 5 years
Number of autotransplanted teeth that fulfill all predefined success criteria at each follow-up visit: Absence of ankylosis Absence of progressive root resorption Physiological mobility Normal percussion sound Functional stability Absence of clinical signs of infection Each autotransplanted tooth is considered an independent observational unit. In participants with more than one autotransplanted tooth, each tooth is evaluated separately.

Trial sites (1)

Facility	City	Region	Status
Dental Esthetic BCN	Barcelona	Barcelons	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07314580 on ClinicalTrials.gov ↗ ← All trials in Spain